FDA recall D-1347-2022

Product

PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34

Reason for recall

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-08-10

Report date

2022-08-24

Termination date

2024-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1347-2022